Informed Consent Using a Spinal Model

NCT06417866 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2024-05-16

No results posted yet for this study

Summary

Informed consent is the first step in every medical procedure. It is important for the patient to clearly understand how the procedure will be performed, what to expect from the process, and the possible complications. Any of the specified processes disruption may alter procedure satisfaction and treatment outcomes. Studies have reported that providing insufficient information before interventional procedures increases anxiety and the severity of pain during the procedure. In this study, alongside the standard procedures for obtaining oral and written consent, it is envisaged to augment patient comprehension and engagement by visually demonstrating the treatment areas and needle insertion points using a spinal model. Within the study framework, patients will be presented with both verbal and written informed consent, supplemented by visual aids utilizing a spinal model. The study aims to assess and compare the efficacy of this enhanced consent process in terms of patient understanding, procedural acceptance, and subsequent satisfaction levels.

Conditions

Interventions

OTHER

informed consent

standard verbal and written informed consent

OTHER

spine model

standard verbal and written informed consent + visual spine model

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Principal Investigators

  • Hanzade A Unal, MD · Ankara University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06417866 on ClinicalTrials.gov